Vietnam MOH registration 240001393/PCBB-HCM

Immuno-quantitative Trypsinogen Test (IRT)

VN: Bộ xét nghiệm định lượng trypsinogen miễn dịch (IRT)

Neonatal IRT Screening ELISA

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Zentech SA·Registered Jul 08, 2024

Registration details

Analysis ID: 240001393/PCBB-HCM
Submission ID: 000.00.19.H29-240607-0013
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Zentech SA
Manufacturer Country: Theo theo phụ lục
Product Owner: Zentech SA
Authorized Representative: CÔNG TY TNHH GAM MA VIỆT BỈ

Technical details

Intended Use: The quantitative determination of trypsinogen immunoreactivity (IRT) in dried blood spots from newborns on filter paper 903 or 226. Medical specialists use the test to screen for cystic fibrosis. The test is performed on a semi-automatic or automatic system.

Dates and status

Registration Date: Jul 08, 2024

About this record

Access comprehensive regulatory information for Immuno-quantitative Trypsinogen Test (IRT) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001393/PCBB-HCM and manufactured by Zentech SA. The authorized representative in Vietnam is CÔNG TY TNHH GAM MA VIỆT BỈ.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.